U.S. patent number 8,758,218 [Application Number 13/453,064] was granted by the patent office on 2014-06-24 for method of treating incontinence and treatment device including non-porous cuff and extending members.
This patent grant is currently assigned to Coloplast A/S. The grantee listed for this patent is Christopher Deegan, Steven McClurg, Mark A. Moschel. Invention is credited to Christopher Deegan, Steven McClurg, Mark A. Moschel.
United States Patent |
8,758,218 |
Deegan , et al. |
June 24, 2014 |
Method of treating incontinence and treatment device including
non-porous cuff and extending members
Abstract
A method of treating urinary incontinence includes making an
incision and exposing tissue of a urethra. The method additionally
includes inserting a non-porous sheet into the incision and forming
a cuff around the urethra with the non-porous sheet by directing a
first end of the non-porous sheet through a slot formed in a second
end of the non-porous sheet. The method additionally includes
directing an extending member that is attached to the non-porous
sheet to a location exterior of a pelvis. The method further
includes configuring the cuff to tighten around the urethra when
pulling on the first end of the non-porous sheet, and configuring
the cuff to be loosely positioned around the urethra when pulling
on the extending member.
Inventors: |
Deegan; Christopher (North St.
Paul, MN), McClurg; Steven (Brooklyn Park, MN), Moschel;
Mark A. (New Hope, MN) |
Applicant: |
Name |
City |
State |
Country |
Type |
Deegan; Christopher
McClurg; Steven
Moschel; Mark A. |
North St. Paul
Brooklyn Park
New Hope |
MN
MN
MN |
US
US
US |
|
|
Assignee: |
Coloplast A/S (Humlebaek,
DK)
|
Family
ID: |
49380728 |
Appl.
No.: |
13/453,064 |
Filed: |
April 23, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20130281766 A1 |
Oct 24, 2013 |
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Current U.S.
Class: |
600/30 |
Current CPC
Class: |
A61F
2/0045 (20130101); A61F 2/042 (20130101); A61F
2002/047 (20130101) |
Current International
Class: |
A61F
2/02 (20060101) |
Field of
Search: |
;600/30 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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02058564 |
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Aug 2002 |
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WO |
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2007002071 |
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Jan 2007 |
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WO |
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Other References
Office Action mailed on Mar. 27, 2013 in U.S. Appl. No. 13/676,132.
cited by applicant .
Office Action mailed on Apr. 25, 2013 in U.S. Appl. No. 13/668,226.
cited by applicant .
Office Action mailed on Nov. 2, 2012 in DK Patent Application No.
PA 2012 70202 Office Action mailed on Nov. 19, 2012 in DK Patent
Application No. PA 2012 70219. cited by applicant .
Final Office Action mailed on Aug. 29, 2013 in U.S. Appl. No.
13/676,132. cited by applicant .
Extended Search Report mailed on Aug. 7, 2013 in EP application No.
13166095.3. cited by applicant.
|
Primary Examiner: Marmor, II; Charles A
Assistant Examiner: McBride; Shannon
Attorney, Agent or Firm: Coloplast Corp., Coloplast A/S
Baumann; Nick
Claims
What is claimed is
1. A method of treating urinary incontinence, the method
comprising: making an incision and exposing tissue of a urethra;
inserting a non-porous sheet into the incision and forming a cuff
around the urethra with the non-porous sheet by directing a first
end of the non-porous sheet through a slot formed in a second end
of the non-porous sheet; directing an extending member that is
attached to the non-porous sheet to a location exterior of a
pelvis; configuring the cuff to tighten around the urethra when
pulling on the first end of the non-porous sheet; configuring the
cuff to be loosely positioned around the urethra when pulling on
the extending member; and implanting the cuff around the urethra,
implanting the first end of the non-porous sheet through a first
obturator foramen of a user, and implanting the extending member
through a second obturator foramen of the user.
2. The method of claim 1, comprising placing the first end of the
non-porous sheet and the extending member through skin of a
user.
3. The method of claim 1, comprising placing the first end of the
non-porous sheet and the extending member through an abdominal wall
of the user.
4. A method of treating urinary incontinence, the method
comprising: making an incision and exposing tissue of a urethra;
inserting a non-porous sheet into the incision and forming a cuff
around the urethra with the non-porous sheet by directing a first
end of the non-porous sheet through a slot formed in a second end
of the non-porous sheet; directing an extending member that is
attached to the non-porous sheet to a location exterior of a
pelvis; configuring the cuff to tighten around the urethra when
pulling on the first end of the non-porous sheet; configuring the
cuff to be loosely positioned around the urethra when pulling on
the extending member; and implanting the cuff around the urethra
and implanting the first end of the non-porous sheet and the
extending member into a scrotum of the user.
Description
BACKGROUND
Devices for treating urinary incontinence include slings, supports,
artificial urinary sphincters and other devices that are implanted
in a user to support and/or coapt the urethra.
A sling is a device that is surgically implanted to support the
urethra and inhibit urine from undesirably leaking from the
urethra. Slings are typically fabricated from mesh and are
implanted through one or more incisions. The sling is secured to
supporting tissue(s) and the tissue eventually grows through the
mesh to support the urethra. The surgeon will peri-operatively
determine and achieve the appropriate level of tension in the sling
relative to the urethra that will post-operatively provide the user
with a continent state.
An artificial urinary sphincter is generally provided as an
inflatable ring or "donut" that is surgically implanted around the
urethra. Some people become incontinent after having a portion or
all of the prostate gland removed, which can result in a loss of
some or all of the function of the prostatic urinary sphincter. An
artificial urinary sphincter implanted around the compromised
prostatic urinary sphincter can provide the patient with improved
control of urinary function.
Improved incontinence treatment devices would be welcomed by both
the patient and the surgical staff.
SUMMARY
One aspect provides an incontinence treatment device including a
non-porous support and an extending member. The non-porous support
has a first end portion provided with a slot and a second end
portion. The second end portion is insertable through the slot to
form a cuff that is configured for placement around a urethra of a
user. The extending member is attached to the support at a junction
located between the first end portion and the second end portion.
Tension applied to the second end portion is adapted to draw the
junction toward the slot to tighten the cuff and thus provide the
user with a continent state. Tension applied to the extending
member is adapted to draw the juncture away from the slot and
expand the cuff and thus allow the user to urinate.
One aspect provides an incontinence treatment device including a
non-porous sheet and an extending member attached to the non-porous
sheet. The non-porous sheet has a first side spaced apart from a
second side by a sheet width, a first end portion having a width
that is approximately equal to the sheet width with a slot formed
in the first end portion, and a second end portion that tapers to a
tapered width that is less than the sheet width. The extending
member has a first end that is attached to the sheet at a junction
located between the first end portion and the second end portion.
The extending member includes a second end that has a width that is
less than the sheet width. The tapered width of the second end
portion of the sheet is insertable through the slot in the first
end portion to form a cuff from the non-porous sheet that is sized
for placement around a human urethra. The slot has a slot width
that prevents the junction from passing through the slot.
One aspect provides a method of treating urinary incontinence that
includes making an incision and exposing tissue of a urethra, and
inserting a non-porous sheet into the incision and forming a cuff
around the urethra with the non-porous sheet by directing a first
end of the non-porous sheet through a slot formed in a second end
of the non-porous sheet. The method further includes directing an
extending member that is attached to the non-porous sheet to a
location outside of the pelvis. The method additionally includes
configuring the cuff to tighten around the urethra when pulling on
the first end of the non-porous sheet, and configuring the cuff to
be loosely positioned around the urethra when pulling on the
extending member.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings are included to provide a further
understanding of embodiments and are incorporated in and constitute
a part of this specification. The drawings illustrate embodiments
and together with the description serve to explain principles of
embodiments. Other embodiments and many of the intended advantages
of embodiments will be readily appreciated as they become better
understood by reference to the following detailed description. The
elements of the drawings are not necessarily to scale relative to
each other. Like reference numerals designate corresponding similar
parts.
FIG. 1 is a top view of one embodiment of an incontinence treatment
device.
FIG. 2 is a perspective view of the incontinence treatment device
illustrated in FIG. 1 as assembled to provide a cuff.
FIG. 3 is a top view of the incontinence treatment device
illustrated in FIG. 2.
FIG. 4A is a top view and FIG. 4B is an expanded view of the
incontinence treatment device illustrated in FIG. 3 with tension
applied to tighten the cuff of the device.
FIG. 4C is a top view of the incontinence treatment device
illustrated in FIG. 4A with tension applied to a second extending
member to loosen the cuff of the device.
FIG. 5 is a schematic view of one embodiment of an incontinence
treatment device with a cuff implanted around the urethra and
extending members directed behind a pubic symphysis and through a
wall of an abdomen.
FIG. 6 is a schematic view of one embodiment of an incontinence
treatment device with a cuff implanted around the urethra and
extending members directed through obturator foramina and through a
groin of a user.
FIG. 7A is a schematic view of one embodiment of an incontinence
treatment device with a cuff loosely implanted around the urethra
and extending members implanted in a scrotum.
FIG. 7B is a schematic view of one embodiment of the incontinence
treatment device illustrated in FIG. 7A with the cuff tightened
around the urethra to provide the user with a continent state.
DETAILED DESCRIPTION
In the following Detailed Description, reference is made to the
accompanying drawings, which form a part hereof, and in which is
shown by way of illustration specific embodiments in which the
invention may be practiced. In this regard, directional
terminology, such as "top," "bottom," "front," "back," "leading,"
"trailing," etc., is used with reference to the orientation of the
Figure(s) being described. Because components of embodiments can be
positioned in a number of different orientations, the directional
terminology is used for purposes of illustration and is in no way
limiting. It is to be understood that other embodiments may be
utilized and structural or logical changes may be made without
departing from the scope of the present invention. The following
detailed description, therefore, is not to be taken in a limiting
sense, and the scope of the present invention is defined by the
appended claims.
It is to be understood that the features of the various exemplary
embodiments described herein may be combined with each other,
unless specifically noted otherwise.
Tissue includes soft tissue, which includes dermal tissue,
sub-dermal tissue, ligaments, tendons, or membranes. As employed in
this specification, the term "tissue" does not include bone.
In this specification the word "coapt" means to close or to
substantially close. To coapt an opening is to bring two surfaces
together in close approximation such that the gap between the two
surfaces is reduced or eliminated. To coapt a urethra means to
substantially yet reversibly close the urethra to impede the
passage of urine and provide a person with a continent state.
In this specification permanent means for as long as an
incontinence treatment device is implanted into a patient. Thus, an
incontinence treatment device having a permanent external portion
outside of an abdominal wall of the patient provides the external
portion outside of the patient for as long as the device is
implanted in the patient.
In this specification a "user" is one into whom an incontinence
treatment device has been implanted.
In this specification "non-porous" means a material with no
through-holes. For example, a non-porous material is characterized
by the absence of multiple holes that extend through the material
from one surface to the other surface. Non-porous, as employed in
this specification, means a material that is configured to prevent
tissue growth through the implanted material.
Embodiments provide an incontinence treatment device implantable
into a user and including extending members that allow the user to
selectively move from a state of continence (free from urine
leakage) to a state that allows urination. Tension applied to a
first extending member is adapted to draw the junction toward the
slot to tighten the cuff and coapt the urethra to provide the user
with a continent state. Tension applied to the second extending
member is adapted to draw the juncture away from the slot and
loosen the cuff to relieve coaptation of the urethra and allow the
user to urinate.
FIG. 1 is a top view of one embodiment of an incontinence treatment
device 20. The incontinence treatment device 20 (device 20)
includes a support 22 in the form of a sheet or a band that extends
between a first end 24 and a second end 26, with a first end
portion 28 adjacent to the first end 24 and a second end portion 30
adjacent to the second end 26. An extending member 32 is attached
to the support 22 at a junction 34 that is located between the
first end portion 28 and the second end portion 30. The support 22
is fabricated to be non-porous such that after implantation the
non-porous support 22 discourages or prevents tissue from growing
onto or through the non-porous support 22.
One of the end portions 28, 30 is provided with a slot 36. For
example, the first end portion 28 is provided with a slot 36 that
is sized to receive the second end portion 30. Inserting the second
end portion 30 through the slot 36, for example along a path 38,
forms the support 22 into a cuff (40 in FIG. 2) with the second end
portion 30 extending in a different direction from the extending
member 32.
Prior to assembly, the device 20 provides three segments or arms: a
first arm A1 that is provided by the first end portion 28 having
the slot 36, a second arm A2 that is provided by the second end
portion 30, and a third arm A3 that is provided by the second
extending member 32.
In one embodiment, the second extending member 32 is attached at a
substantially orthogonal angle to the support 22. In one
embodiment, the second extending member 32 is attached to the
support 22 at an angle other than 90 degrees.
FIG. 2 is a perspective view and FIG. 3 is a top view of the
support 22 providing a cuff 40. The cuff 40 has two adjustment
arms, a tightening arm provided by the second end portion 30 and a
loosening arm provided by extending member 32.
During implantation, the support 22 is placed on a first side of
the urethra and the second end portion 30 is inserted through the
slot 36 to form the cuff 40 around the urethra of a user. The
assembled cuff 40 thus has two extending members: a first extending
member 42 provided by the second end portion 30 and the second
extending member 32 attached to the support 22 between the first
end portion 28 and the second end portion 30.
In one embodiment, the slot 36 is formed to have a slot width W
(FIG. 2). In one embodiment, the junction 34 between the member 32
and the support 22 includes a stopper 44 with a stop width S that
is larger than the slot width W. The stop width S of the stopper 44
is configured to prevent the junction 34 from passing through the
slot 36. In one embodiment, the slot width W is sized to prevent
passage of the extending member 32 through the slot 36.
In one embodiment, the support 22 has a height H extending between
opposing sides of the support 22, and each of the first extending
member 42 and the second extending member 32 tapers from a first
width L that is substantially equal to the height H of the support
22 to a second width D that is narrower than the height H of the
support.
The support 22 is non-porous and is preferably fabricated from a
synthetic material such as rubber, silicone, thermoplastic polymer,
thermoset polymer, or blends of polymers or copolymers. One
suitable material for fabricating the support 22 is silicone
rubber. The support 22 is fabricated to be non-porous to discourage
tissue growth through the surface of the support 22.
In one embodiment, at least the cuff 40 portion of the device 20 is
coated with a substance that prevents tissue from attaching to or
growing on a surface of the cuff 40. Tissue growth into or through
the support 22 would undesirably fixate the support 22 into the
patient after it is implanted. The support 22 is fabricated from
materials that are non-porous and are selected to reduce or prevent
the likelihood of tissue growth into or through the support 22.
Although not bound to this theory, tissue is expected to grow
around the cuff 40 and envelop the cuff 40 in a pocket of tissue
that allows the cuff 40 to move (tighten and loosen) relative to
the urethra.
In one embodiment, since the non-porous support 22 is not a mesh.
In one embodiment, the non-porous support 22 has a thickness and is
fabricated from, for example, a solid film having substantially
uniform density through the thickness. Thus, in one embodiment, the
support 22 and the resulting assembled cuff 40 are not
inflatable.
FIG. 4A is a top view and FIG. 4B is an expanded view of the cuff
40. Tension T1 illustrates a pulling force applied to the first
extending member 42. The tension T1 will draw the junction 34 up to
the slot 36 and reduce the diameter of the cuff 40, which is useful
to coapt the urethra to provide the user with a continent state.
With reference to FIG. 4B, the tension T1 applied to the first
extending member 42 tightens the cuff 40 until a stopper 44 is
caught by the slot 36, which prevents further collapse of the cuff
40.
The arc length of the support 22 extending from the junction 34 to
the slot 36 (See FIG. 1) is selected such that the cuff 40 provides
an inside diameter that is sufficient to collapse or coapt a human
urethra without over compressing or eroding the urethra. The
stopper 44 thus provides a feature that prevents the cuff 40 from
being collapsed too tightly against the urethra.
FIG. 4C is a top view illustrating a second tension T2 applied to
the second extending member 32 to draw the stopper 44 away from the
slot 36, which expands the cuff 40 to relieve coaptation of the
urethra to allow the user to urinate.
When implanted, the cuff 40 provides the user with the ability to
pull on the first extending member 42 to achieve a continent state,
and to subsequently pull on the second extending member 32 to
transition the user into a state that allows urine to pass through
the urethra.
In one embodiment, the cuff 40 is user-activated with each of the
first and second extending members 42, 32, respectively, implanted
to be accessible to the user such that user-applied tension T1
applied to the first extending member 42 will coapt the urethra to
provide the user with a continent state, and user-applied tension
T2 applied to the second extending member 32 will relieve the
coaptation of the urethra and allow the user to urinate.
FIG. 5 is a schematic view of one embodiment of the device 20 after
implantation. The cuff 40 is implanted around the urethra U and the
extending members 32, 42 are tunneled behind the pubic bone PB and
project through a wall of the abdomen. The extending members 32, 42
are located in a user-accessible location outside the body. Tension
applied by the user to the first extending member 42 tightens the
cuff 40 to coapt the urethra and provide the user with a continent
state. Tension applied by the user to the second extending member
32 loosens the cuff 40 to relieve the coaptation of the urethra and
allow the user to urinate.
In one embodiment, the device 20 is implanted into the patient such
that the cuff 40 surrounds the urethra U and the extending members
32, 42 exit through the skin of the abdomen of the user. In one the
suitable implantation approach, a perineal incision (male) or a
vaginal incision (female) is made, and tissue surrounding the
urethra U is dissected to gain access to the urethra U. A portion
of the device 20 is inserted into the incision. With reference to
FIG. 1, the second end portion 30 is subsequently maneuvered around
the urethra U and inserted through the slot 36 in the first end
portion 28 to form the cuff 40 around the urethra U. A suitable
tunneling device, such as a pointed introducer 50 or needle-like
device, is inserted through the skin of the abdomen at an access
point in an abdominal location that is superior to the pubic
symphysis PS. The introducer 50 is tunneled downward toward the
urethra U and exits the incision formed in the patient. One of the
extending members 32, 42 is engaged with a T-slot 52 formed in an
end portion 54 of the introducer 50, and the introducer 50 is
retracted upwards behind the pubic bone PB and out of the access
point formed in the abdominal location. This maneuver is repeated
on the contralateral side, in which the pointed introducer 50 is
inserted through the skin and into the abdomen at a second access
point that is superior to the pubic symphysis PS and again tunneled
downward to exit the incision formed in the patient. The other of
the extending members 32, 42 is engaged with the slot 52 of the
introducer 50, and the introducer 50 is retracted upwards behind
the pubic bone PB and out of the second access point formed in the
abdomen.
The perineal or the vaginal incision is closed. The extending
members 32, 42 project outward from the abdomen through the access
points formed in the abdominal locations. A suitable barrier is
provided to prevent the transmission of bacteria into the abdominal
locations. In other approaches, a prophylactic antibiotic is
employed to reduce infection at the abdominal locations.
The first and second extending members 42, 32, respectively, are
thus accessible to the user. Tension applied to the first extending
member 42 will tighten the cuff 40 to coapt the urethra U. Tension
applied to the second extending member 32 will expand the cuff 40
to allow the user to pass urine through the urethra U.
FIG. 6 is a schematic view of one embodiment of the cuff 40
implanted around the urethra U with each of the extending members
32, 42 directed through one of the obturator foramina OF and out of
the groin to a user-accessible location.
In one embodiment, the device 20 is implanted into the patient such
that the cuff 40 surrounds the urethra U and the extending members
32, 42 extend through an obturator foramen and out of the skin of
the groin. In one suitable implantation approach, a perineal
incision (male) or a vaginal incision (female) is made, and tissue
surrounding urethra is dissected to gain access to the urethra U.
With reference to FIG. 1, the second end portion 30 is maneuvered
around the urethra U and inserted through the slot 36 in the first
end portion 28 to form the cuff 40 around the urethra U. The ends
of the extending members 32, 42 are suitably tunneled through each
of the obturator foramen OF and out of the skin in the region of
the groin.
In one embodiment, an introducer 60A is employed in an "inside out"
approach to tunnel the ends of the extending members 32, 42 out of
the skin of the groin. For example, an end of the second extending
member 32 is engaged with a tip 62 of the introducer 60A at a
location outside of the incision (perineal for male or vaginal for
female). The introducer 60A is suitable curved to allow the end of
the extending member 32 to be directed behind the descending pubic
ramus PR, through one of the obturator foramen OF, and out of the
skin in the region of the groin. A similar maneuver is repeated on
the contralateral side with a suitably formed second introducer 60B
to direct the end of the extending member 42 through the other
obturator foramen OF.
Another suitable approach directs an introducer through an "outside
in" approach in which the introducer enters the skin in the groin
region, penetrates the obturator foramen OF, and is directed around
the descending pubic ramus PR until a tip of the introducer exits
the incision. The tip of the introducer is coupled with an end of
one of the extending members 32, 42, and the introducer is
retrieved back through the incision, the obturator foramen OF, and
the skin in the groin region. A similar maneuver is repeated on the
contralateral side to place the other of the extending members 32,
42.
Thus, as illustrated in FIG. 6, each of the first and second
extending members 42, 32, respectively, is implanted through one of
the obturator foramen and extends to the skin to a user-accessible
location.
FIG. 7A is a schematic view of one embodiment of an open cuff 40
implanted around the urethra U and FIG. 7B is a schematic view of
the cuff 40 coapting the urethra U.
In one embodiment, the extending members 32, 42 are implanted in a
scrotum of a male user, and although implanted internal to the
user, are accessible for selectively altering the user between a
continent state and a urination state.
Similar to the approaches described above, an incision is made, and
tissue surrounding urethra is dissected to gain access to the
urethra U. The non-porous sheet 22 is maneuvered around the urethra
U to form the cuff 40 around the urethra U. The ends of the
extending members 32, 42 are directed into the scrotum Sc and the
incision is closed.
The user pulls on the extending members 32, 42 through the skin of
the scrotum to adjust the cuff 40 between the tightened and coapted
state and the loosened and open states. FIG. 7A illustrates the
second extending member 32 activated or pulled to open the cuff 40.
In this configuration, the user is provided with an opened cuff 40
that allows the user to pass urine through the urethra U.
FIG. 7B illustrates the first extending member 42 tensioned or
otherwise pulled to collapse the cuff 40 around the urethra U,
which provides the user with a continent state.
Although specific embodiments have been illustrated and described
herein, it will be appreciated by those of ordinary skill in the
art that a variety of alternate and/or equivalent implementations
may be substituted for the specific embodiments shown and described
without departing from the scope of the present invention. This
application is intended to cover any adaptations or variations of
medical devices as discussed herein. Therefore, it is intended that
this invention be limited only by the claims and the equivalents
thereof.
* * * * *